Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aiviva, Algernon, Astrazeneca, Cytokinetics, Epygenix, Kyowa, Mei, Otonomy, RVL, Synthetic Biologics, Xencor.
DUBLIN – The ongoing legal uncertainty surrounding the transfer of data from European research institutions or companies to international partners shows little sign of resolution, despite the urgency of the COVID-19 pandemic, which has engendered an extraordinary collaborative response from the global scientific community.
With phase III vaccine trials nearly enrolled and data expected soon, a half-year of expedited development efforts, plus massive government funding may soon provide the ammunition needed to effectively stop the SARS-CoV-2 scourge of 2020.
FDA enforcement of clinical research regulations has often been "light-handed, slow-moving, and secretive," a new look at the agency's enforcement track record concludes. Published today in the journal Science, the analysis said the shortcomings may be harming both patients and trial integrity.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Aegle, Akari, Baylx, Ionis, Irlab, Kadmon, Pfizer, Provention, Solid, Teneobio, Zosano.
As his firm unveiled early data with its spike protein-targeting COVID-19 therapy, Regeneron Pharmaceuticals Inc.’s chief scientific officer, George Yancopoulos, said that, even if researchers come up with a drug that works, coming up with efficient point-of-care diagnostics remains “a major societal imperative.”
CAJICA, Colombia – Privately held Inosan Biopharma SA De Cv, of Mexico City, is racing to develop a biological treatment to cure COVID-19 patients. Inosan has mastered the technique of using horses to produce antibodies to heal patients bitten by poisonous creatures, such as snakes, spiders and scorpions.
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